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K Number
K011204
Device Name
NEUROFAX, MODELS EEG-1100A, EEG-9100A
Manufacturer
NIHON KOHDEN AMERICA, INC.
Date Cleared
2001-05-08

(19 days)

Product Code
OLV
Regulation Number
882.1400
Type
Special
Panel
NE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

§ 882.1400 Electroencephalograph.

(a)
Identification. An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.(b)
Classification. Class II (performance standards).